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Numerous accelerometers and prediction methods are used to estimate energy expenditure (EE). Validation studies have been limited to small sample sizes in which participants complete a narrow range of activities and typically validate only one or two prediction models for one particular accelerometer. The purpose of this study was to evaluate the validity of nine published and two proprietary EE prediction equations for three different accelerometers. Two hundred and seventy-seven participants completed an average of six treadmill (TRD) (1.34, 1.56, 2.23 ms −1 each at 0 and 3% grade) and five self-paced activities of daily living (ADLs). EE estimates were compared with indirect calorimetry. Accelerometers were worn while EE was measured using a portable metabolic unit. To estimate EE, 4 ActiGraph prediction models were used, 5 Actical models, and 2 RT3 proprietary models. Across all activities, each equation underestimated EE (bias −0.1 to −1.4 METs and −0.5 to −1.3 kcal, respectively). For ADLs EE was underestimated by all prediction models (bias −0.2 to −2.0 and −0.2 to −2.8, respectively), while TRD activities were underestimated by seven equations, and overestimated by four equations (bias −0.8 to 0.2 METs and −0.4 to 0.5 kcal, respectively). Misclassification rates ranged from 21.7 (95% CI 20.4, 24.2%) to 34.3% (95% CI 32.3, 36.3%), with vigorous intensity activities being most often misclassified. Prediction equations did not yield accurate point estimates of EE across a broad range of activities nor were they accurate at classifying activities across a range of intensities (light <3 METs, moderate 3–5.99 METs, vigorous ≥6 METs). Current prediction techniques have many limitations when translating accelerometer counts to EE.

Abstract Objective To update the “Testosterone Therapy in Men With Androgen Deficiency Syndromes” guideline published in 2010. Participants The participants include an Endocrine Society–appointed task force of 10 medical content experts and a clinical practice guideline methodologist. Evidence This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus Process One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline. Conclusions We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy. This update to the Endocrine Society’s 2010 testosterone guideline, prepared by an expert panel, describes the diagnosis, screening, treatment, and monitoring of hypogonadal men.

Background Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT ( P opulation, I ntervention, C omparator, O utcome, T ime-frame) format is associated with a better reporting quality of randomized controlled trials (RCTs). Methods We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1) a 14-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials; and 2) a 3-point key score (KS), based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model. Results A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR) = 1.021, 95% CI: 1.012 to 1.029) and KS (IRR = 1.142, 95% CI: 1.079 to 1.210). A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132) and KS (IRR = 1.530, 95% CI 1.311-1.786). Conclusions Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect is small - and better reporting of key methodologies.

Abstract Background Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain. Objective To develop clinical guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing. Methods A multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined “empiric supplementation” as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations. The process to develop this clinical guideline did not use a risk assessment framework and was not designed to replace current DRI for vitamin D. Results The panel suggests empiric vitamin D supplementation for children and adolescents aged 1 to 18 years to prevent nutritional rickets and because of its potential to lower the risk of respiratory tract infections; for those aged 75 years and older because of its potential to lower the risk of mortality; for those who are pregnant because of its potential to lower the risk of preeclampsia, intra-uterine mortality, preterm birth, small-for-gestational-age birth, and neonatal mortality; and for those with high-risk prediabetes because of its potential to reduce progression to diabetes. Because the vitamin D doses in the included clinical trials varied considerably and many trial participants were allowed to continue their own vitamin D–containing supplements, the optimal doses for empiric vitamin D supplementation remain unclear for the populations considered. For nonpregnant people older than 50 years for whom vitamin D is indicated, the panel suggests supplementation via daily administration of vitamin D, rather than intermittent use of high doses. The panel suggests against empiric vitamin D supplementation above the current DRI to lower the risk of disease in healthy adults younger than 75 years. No clinical trial evidence was found to support routine screening for 25(OH)D in the general population, nor in those with obesity or dark complexion, and there was no clear evidence defining the optimal target level of 25(OH)D required for disease prevention in the populations considered; thus, the panel suggests against routine 25(OH)D testing in all populations considered. The panel judged that, in most situations, empiric vitamin D supplementation is inexpensive, feasible, acceptable to both healthy individuals and health care professionals, and has no negative effect on health equity. Conclusion The panel suggests empiric vitamin D for those aged 1 to 18 years and adults over 75 years of age, those who are pregnant, and those with high-risk prediabetes. Due to the scarcity of natural food sources rich in vitamin D, empiric supplementation can be achieved through a combination of fortified foods and supplements that contain vitamin D. Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications. These recommendations are not meant to replace the current DRIs for vitamin D, nor do they apply to people with established indications for vitamin D treatment or 25(OH)D testing. Further research is needed to determine optimal 25(OH)D levels for specific health benefits.

ObjectiveTo update the “Endocrine Treatment of Transsexual Persons: An Endocrine Society Clinical Practice Guideline,” published by the Endocrine Society in 2009.ParticipantsThe participants include an Endocrine Society–appointed task force of nine experts, a methodologist, and a medical writer.EvidenceThis evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies.Consensus ProcessGroup meetings, conference calls, and e-mail communications enabled consensus. Endocrine Society committees, members and cosponsoring organizations reviewed and commented on preliminary drafts of the guidelines.ConclusionGender affirmation is multidisciplinary treatment in which endocrinologists play an important role. Gender-dysphoric/gender-incongruent persons seek and/or are referred to endocrinologists to develop the physical characteristics of the affirmed gender. They require a safe and effective hormone regimen that will (1) suppress endogenous sex hormone secretion determined by the person’s genetic/gonadal sex and (2) maintain sex hormone levels within the normal range for the person’s affirmed gender. Hormone treatment is not recommended for prepubertal gender-dysphoric/gender-incongruent persons. Those clinicians who recommend gender-affirming endocrine treatments—appropriately trained diagnosing clinicians (required), a mental health provider for adolescents (required) and mental health professional for adults (recommended)—should be knowledgeable about the diagnostic criteria and criteria for gender-affirming treatment, have sufficient training and experience in assessing psychopathology, and be willing to participate in the ongoing care throughout the endocrine transition. We recommend treating gender-dysphoric/gender-incongruent adolescents who have entered puberty at Tanner Stage G2/B2 by suppression with gonadotropin-releasing hormone agonists. Clinicians may add gender-affirming hormones after a multidisciplinary team has confirmed the persistence of gender dysphoria/gender incongruence and sufficient mental capacity to give informed consent to this partially irreversible treatment. Most adolescents have this capacity by age 16 years old. We recognize that there may be compelling reasons to initiate sex hormone treatment prior to age 16 years, although there is minimal published experience treating prior to 13.5 to 14 years of age. For the care of peripubertal youths and older adolescents, we recommend that an expert multidisciplinary team comprised of medical professionals and mental health professionals manage this treatment. The treating physician must confirm the criteria for treatment used by the referring mental health practitioner and collaborate with them in decisions about gender-affirming surgery in older adolescents. For adult gender-dysphoric/gender-incongruent persons, the treating clinicians (collectively) should have expertise in transgender-specific diagnostic criteria, mental health, primary care, hormone treatment, and surgery, as needed by the patient. We suggest maintaining physiologic levels of gender-appropriate hormones and monitoring for known risks and complications. When high doses of sex steroids are required to suppress endogenous sex steroids and/or in advanced age, clinicians may consider surgically removing natal gonads along with reducing sex steroid treatment. Clinicians should monitor both transgender males (female to male) and transgender females (male to female) for reproductive organ cancer risk when surgical removal is incomplete. Additionally, clinicians should persistently monitor adverse effects of sex steroids. For gender-affirming surgeries in adults, the treating physician must collaborate with and confirm the criteria for treatment used by the referring physician. Clinicians should avoid harming individuals (via hormone treatment) who have conditions other than gender dysphoria/gender incongruence and who may not benefit from the physical changes associated with this treatment.Gender affirmation is multidisciplinary treatment. Gender-dysphoric/gender-incongruent persons seek and/or are referred to endocrinologists to develop the physical characteristics of the affirmed gender.

The possibility of other types of diabetes should be considered in the child who has negative diabetes-associated autoantibodies and (B): an autosomal dominant family history of diabetes (maturity-onset diabetes of the young [MODY]) age less than 12 months and especially in first 6 months of life (NDM [neonatal diabetes mellitus]) mild-fasting hyperglycemia (5.5-8.5 mmol [100-150 mg/dL]), especially if young, non-obese, and asymptomatic a prolonged honeymoon period over 1 year or an unusually low requirement for insulin of ≤0.5 U/kg/day after 1 year of diabetes associated conditions such as deafness, optic atrophy, or syndromic features (mitochondrial disease) a history of exposure to drugs known to be toxic to β-cells or cause insulin resistance (eg, immunosuppressive drugs such as tacrolimus or cyclosporin; gluocorticoids or some antidepressants). While type 1 diabetes remains the most common form of diabetes in young people in many populations, especially those of European background, type 2 diabetes has become an increasingly important public health concern globally among children in high risk ethnic populations as well as in those with severe obesity, see ISPAD guideline on type 2 diabetes . Diabetes in young people usually presents with characteristic symptoms such as polyuria, polydipsia, nocturia, enuresis, weight loss—which may be accompanied by polyphagia, behavioral disturbance including reduced school performance, and blurred vision. Glycated hemoglobin (HbA1c) can be used as a diagnostic test for diabetes providing that stringent quality assurance tests are in place and assays are standardized to criteria aligned to the international reference values, and there are no conditions present which preclude its accurate measurement. [...]the validity of HbA1c as a measure of average glucose is complicated in the context of hemoglobinopathies, certain forms of anemia, or any other condition that affects normal red blood cell turnover.

Abstract Glucocorticoids are widely prescribed as anti-inflammatory and immunosuppressive agents. This results in at least 1% of the population using chronic glucocorticoid therapy, being at risk for glucocorticoid-induced adrenal insufficiency. This risk is dependent on the dose, duration and potency of the glucocorticoid, route of administration, and individual susceptibility. Once glucocorticoid-induced adrenal insufficiency develops or is suspected, it necessitates careful education and management of affected patients. Tapering glucocorticoids can be challenging when symptoms of glucocorticoid withdrawal develop, which overlap with those of adrenal insufficiency. In general, tapering of glucocorticoids can be more rapidly within a supraphysiological range, followed by a slower taper when on physiological glucocorticoid dosing. The degree and persistence of HPA axis suppression after cessation of glucocorticoid therapy are dependent on overall exposure and recovery of adrenal function varies greatly amongst individuals. This first European Society of Endocrinology/Endocrine Society joint clinical practice guideline provides guidance on this clinically relevant condition to aid clinicians involved in the care of patients on chronic glucocorticoid therapy.

Imaging is an essential tool in research, diagnostics and the management of endocrine disorders. Ultrasonography, nuclear medicine techniques, MRI, CT and optical methods are already used for applications in endocrinology. Optoacoustic imaging, also termed photoacoustic imaging, is emerging as a method for visualizing endocrine physiology and disease at different scales of detail: microscopic, mesoscopic and macroscopic. Optoacoustic contrast arises from endogenous light absorbers, such as oxygenated and deoxygenated haemoglobin, lipids and water, or exogenous contrast agents, and reveals tissue vasculature, perfusion, oxygenation, metabolic activity and inflammation. The development of high-performance optoacoustic scanners for use in humans has given rise to a variety of clinical investigations, which complement the use of the technology in preclinical research. Here, we review key progress with optoacoustic imaging technology as it relates to applications in endocrinology; for example, to visualize thyroid morphology and function, and the microvasculature in diabetes mellitus or adipose tissue metabolism, with particular focus on multispectral optoacoustic tomography and raster-scan optoacoustic mesoscopy. We explain the merits of optoacoustic microscopy and focus on mid-infrared optoacoustic microscopy, which enables label-free imaging of metabolites in cells and tissues. We showcase current optoacoustic applications within endocrinology and discuss the potential of these technologies to advance research and clinical practice.Optoacoustic imaging enables the non-invasive and label-free imaging of the structure and function of organs, tissues and cells. This Review highlights key progress with optoacoustic imaging technology for applications in endocrinology and metabolism, with a specific focus on multispectral optoacoustic tomography and raster-scan optoacoustic mesoscopy.

Urinary glucose screening in Japanese and Taiwanese adolescents may be a unique situation with demonstrated cost-effectiveness (A) Testing to identify clinical cases of diabetes should be considered in children and adolescents after the onset of puberty or after 10 years of age, whichever occurs earlier, who have risk factors for diabetes (obesity, intrauterine growth retardation with rapid infant weight gain, first-degree family history of T2DM, maternal history of diabetes or gestational diabetes during child's gestation, high-risk ethnicity, polycystic ovary syndrome). (A) Clinical testing for dysglycemia in obese at-risk youth should occur in the setting of clinical assessment of other obesity-related comorbidities (non-alcoholic fatty liver disease [NAFLD], dyslipidemia, elevated blood pressure [BP], polycystic ovary syndrome) that are more prevalent than dysglycemia (A) Diagnosis and determination of diabetes type T2DM in youth should be diagnosed using American Diabetes Association (ADA) criteria (A) Diagnosis can be made based on fasting glucose, or 2-hour glucose concentration during an oral glucose tolerance test (OGTT) or hemoglobin A1c (HbA1c) (B) In the absence of symptoms, testing should be confirmed with a repeat test on a different day Clinicians should be aware of the weaknesses of each diagnostic test Diabetes autoantibody testing should be considered in all pediatric patients with the clinical diagnosis of diabetes because of the high frequency of islet cell autoimmunity in otherwise “typical” T2DM (B) Pre-pubertal children are unlikely to have T2DM even if obese (A) Antibodies will indicate the diagnosis of T1DM and an earlier need for insulin (A) Antibodies will indicate the need to consider the presence of other associated autoimmune disorders (A) Diabetes autoantibody testing should be considered in overweight/obese pubertal children with a clinical picture of T1DM (A) The presence of clinically relevant comorbidities should be assessed at the time of diagnosis (A), including hypertension, dyslipidemia, elevation of liver enzymes, and elevated urine albumin/creatinine ratio (ACR) Patients should be screened for obstructive sleep apnea (OSA), depression/anxiety, eating disorders, and impairment of cognition at the time of diagnosis (E). (B) If repeat fasting LDL-C > 130 mg/dL (>3.4 mmol/L): begin medication with an initial goal of <130 mg/dL (<3.4 mmol/L): and an ideal target of <100 mg/dL (2.6 mmol/L (B) Statin therapy has been shown to be safe and effective in adolescents (A) The risks of pregnancy should be re-emphasized Triglycerides If triglycerides are >400 mg/dL fasting (>5.6 mmol/L) or >1000 mg/dL (>11.3 mmol/L) non-fasting: begin medication with a goal of <400 mg/dL (>5.6 mmol/L) fasting (to reduce risk for pancreatitis) (C) Fibrates are the preferred medication category for hypertriglyceridemia and have been shown to be safe and effective in adolescents (A) Retinal examination should be performed at diagnosis and annually thereafter (A) Evaluation for NAFLD and non-alcoholic Steatohepatitis (NASH) by measuring ALT and AST should be done at diagnosis and annually thereafter (A) Interpretation of ALT should be based upon sex-specific upper limits of normal in children (22 U/L for girls and 26 U/L for boys) and not individual laboratory upper limits of normal. [...]the prevalence of prediabetes, defined in adults as a state of high-risk for progression to diabetes, is increasing quickly in some developing countries with the increase of overweight and obesity. Because of the relatively recent emergence of the problem in children and adolescents, there has been a limited evidence base leading to unique challenges in the diagnosis, management, and monitoring of these individuals.